INDICATION: SUBLOCADE (buprenorphine extended-release) injection, for subcutaneous use (CIII) is a prescription medicine used to treat adults with moderate to severe addiction (dependence) to opioid drugs (prescription or illegal) who have received an oral transmucosal (used under the tongue or inside the cheek) buprenorphine-containing medicine at a dose that controls withdrawal symptoms for at least 7 days. SUBLOCADE is part of a complete treatment plan that should include counseling.

Sublocade.com Privacy Policy

Indivior Inc., a subsidiary of Indivior PLC, has outlined below its responsibility to its users and their privacy below.

If you have an unresolved privacy or data use concern that we have not addressed satisfactorily, please contact Indivior Inc.

1. What this Privacy Policy Covers

Indivior Inc. ("Indivior," "we," "us," and/or "our,") respects the privacy of every individual ("You," or individually each a "User" and collectively "Users") who visits and uses sublocade.com and sublocade.com/hcp and their associated products and services or responds to our interactive advertisements (the "Site"). This Privacy Policy outlines the information provided to us by you as a User of the site or that Indivior will collect and how we will use, and may, in some instances, share that information. It also describes the choices available to you regarding our use of your personal information and how you can access and update this information.

This Privacy Policy is part of and incorporated into the Terms of Use, found at sublocade.com/terms-of-use which is a legally binding agreement between Indivior and you.

Please read this policy carefully to understand our policies and practices regarding your information and how we will treat it. If you do not agree with our policies and practices, your choice is not to use our Site. BY ACCESSING, BROWSING, OR USING THE SITE, YOU ACKNOWLEDGE THAT YOU HAVE RECEIVED, READ, UNDERSTOOD, AND AGREE TO BE BOUND BY THE FOLLOWING PRIVACY POLICY, AND ANY UPDATES TO IT.

YOU FURTHERMORE ACKNOWLEDGE AND AGREE THAT INDIVIOR IS NOT A MEDICAL PRACTICE AND DOES NOT PROVIDE MEDICAL ADVICE.

When we use these capitalized terms, they have the following definitions:

"Disclose" (and variations such as "Disclosure") means any and all of the following: using, accessing (or barring access), processing, fulfilling, disclosing, receiving, displaying, sharing, making available, transferring, storing, selling, leasing, licensing, retaining, deleting or destroying, combining, investigating, verifying, proving, enforcing and otherwise dealing with, voluntarily or involuntarily, Personal Information.

"Personal information," "personal information" or "PI" means information that we are required by law to protect and that: (a) personally identifies you, or (b) to the extent required by law, reasonably can be used specifically to identify you or your computing device.

2. Personal Information

Indivior will collect certain personal information that you provide to us voluntarily. For example, and not by limitation, we may collect personal information when you fill out a questionnaire; sign up for a survey or otherwise interact with us. Such information may include, but may not be limited to, your name, address, phone number and email address. In addition to providing you with the service or information you request on our Site, your PI may also be used to help us track the way you use our Site and our products.

Healthcare providers who register to use services provided on this Site may need to furnish PI about another individual (e.g., a patient). We will use the PI you submit to provide the services you request consistent with this Privacy Policy. If you are a healthcare provider and you disclose PI to us, you and you alone bear the sole obligation and responsibility of obtaining any patient consents and authorizations for such disclosures that may be required under federal and state law.

When you access and use our web site (sublocade.com) through your mobile device, we automatically collect information on the type of device you use, operating system version, and the device identifier.

a. Future Communications from Indivior Inc.

When you provide Personal Information to us, we may ask if you want to receive future communication from us, such as newsletters, email or other information. You can choose not to receive this communication, if you wish, and you may opt-out by clicking on the link on the bottom of an email you received or by clicking here.

We may also send you service-related email announcements on rare occasions when it is necessary to do so. For instance, if our service is temporarily suspended for maintenance, we might send you an email. You do not have an option to opt out of these emails, which are not promotional in nature.

b. What Indivior Inc. Tends to do With Personal Information Collected

We may combine the information you provide with information that we collect separately, including information you have provided to other organizations as well as public information (USPS, Yellow Pages, etc.). All of this will help us, for instance, better design our products, Sites and advertisements. In order to do this, we may also share your information with companies who carry out work for us. Information may be shared with service providers who provide services for or administer activities on behalf of Indivior. Information you submit to one or more of the Indivior brands may be shared with another of the Indivior brands. Your Personal Information may also be shared with service providers who warehouse product, perform order fulfillment or provide hosting services. These companies have agreed to only use your information in the way we tell them and to have procedures in place to protect the information.

We will share your Personal Information with third parties only in the ways that are described in this Privacy Policy. We do not sell your Personal Information to third parties.

In the event Indivior, or its assets, is bought or sold, Personal Information may be included among the transferred business assets. In this case, a prominent notice on our Site of any change in ownership or uses of your Personal Information, as well as any choices you may have regarding your Personal Information will be provided.

Indivior may disclose specific Personal Information if it determines that such disclosure is necessary to comply with the law, such as to comply with a subpoena or to protect the safety of the public. When we believe in good faith that disclosure is necessary to protect our rights, protect your safety or the safety of others, or respond to a government request, we may disclose Personal Information. This includes exchanging information with other companies and organizations for fraud protection and credit risk reduction.

If we intend to share your information with an unaffiliated company, other than as set out above, we will contact you first and give you the opportunity to remove your information from our database.

3. Children's Privacy

This Site is not intended to be used by anyone under the age of 18 and we do not want to collect information from anyone under 18. If a child's parent or a guardian believes their child may have provided PI to us, write us at our Legal Notices Address and we will use commercially reasonable efforts to delete that PI, subject to applicable law and this Privacy Policy.

4. Linked Sites

The Indivior Site(s) may contain links to other websites. The Privacy Policies at these other websites may be different from this one. When leaving an Indivior site, you should refer to the Privacy Policy of both our Site(s) and the third-party website(s), as they may differ. You agree, however, that if they provide PI back to us, we may apply this Privacy Policy to what we receive.

5. Cookies and Other Tracking Technologies

Technologies such as cookies, tags and scripts are used by Indivior Inc. and our marketing agency partners, affiliates, or analytics or service providers. These technologies are used in analyzing trends, administering the website, tracking users' movements around the website and to gather demographic information about our user base as a whole. We may receive reports based on the use of these technologies by these companies on an individual as well as aggregated basis.

We use cookies for purposes such as streamlining user experience, remembering users' settings, and for authentication. Users can control the use of cookies at the individual browser level. If you reject cookies, you may still use our website, but your ability to use some features or areas of our website may be limited.

  • Log Files

As is true of most websites, we gather certain information automatically and store it in log files. This information may include internet protocol (IP) addresses, browser type, internet service provider (ISP), referring/exit pages, operating system, date/time stamp, and/or clickstream data. We may combine this automatically collected log information with other information we collect about you. We may do this to improve our services and communications, or to improve site functionality.

Mobile Analytics

We use mobile analytics software to allow us to better understand the functionality of our mobile website when you access it through your mobile device. This software may record information such as how often you use the mobile site, the events that occur within the mobile site, aggregated usage, performance data, and where the mobile site was accessed from. We do not link the information we store within the analytics software to any personal information you submit within the mobile site.

We partner with a third-party ad network to either display advertising on our Site or to manage our advertising on other websites. Our ad network partner uses cookies and web beacons to collect non-personal information about your activities on this Site and other websites to provide you targeted advertising based upon your interests. If you wish to not have this information used for the purpose of serving you targeted ads, you may opt-out by clicking here (or if located in the European Union click here). Please note this does not opt you out of being served advertising. You will continue to receive non-sponsored ads.

6. How Your Information is Protected

Indivior uses industry standard security techniques to help protect against the loss, misuse or alteration of information collected from you at an Indivior Site. When you transmit Personal Information, that information is stored on servers that Indivior has attempted to secure from unauthorized access or intrusion. Of course, the Indivior Sites cannot be and are not responsible for unauthorized access to information by hackers who have obtained such access through illegal measures.

Unfortunately, the transmission of information via the internet is not completely secure. Although we will do our best to protect your Personal Information, we cannot guarantee the security of the Personal Information you transmit to our Site; any transmission is at your own risk.

While we cannot guarantee that loss, misuse or alteration to data will not occur, once we have received your information, we will make reasonable efforts to prevent such occurrences.

7. Who to Contact

If you have submitted Personal Information through an Indivior Site or interactive advertisement, and would like that information modified, changed or deleted from our records, please click here to provide us with your request and the email address you provided. We will respond to your inquiry within 30 days.

If you think we are in default under this Privacy Policy, you may contact us at Our Legal Notices Address:

Indivior Inc.
10710 Midlothian Turnpike
North Chesterfield, VA 23235
Attn: Legal Department
Email: Indivior_Privacy@indivior.com

8. How You Can Update, Change or Delete Your Information

If at any time you want to update, change or delete your information, you may log in to the Site where you have your information and make those changes on your profile page. If you do not want your PI collected, please do not submit it to us. If you have received an email and you would like to opt-out of receiving future emails, please click on the opt-out link at the bottom of that email or please click here to opt-out.

Please note that we do not maintain all PI in a form that can be accessed or updated by you and some PI may not be changed (e.g., payment records). Accordingly and subject to applicable law, we will determine what may be accessed and how; we may also keep a record of changes (including deletions) and disclose them for lawful purposes.

We keep PI for as long as your account is active or as needed to provide you services and reserve the right to retain it to the full extent not prohibited by law (e.g., for the length of a statute of limitations). We may discard PI at our discretion, so you should retain your own records. Often it is not feasible or advisable to actually discard PI (such as commingled PI), so we reserve the right to retain and treat it as inactive or discarded (such as removing traditional "pointers" to it).

You may make a request for us to update eligible PI by writing to us at our Legal Notice Address. If applicable law requires us to accept requests by other means, use our address to obtain information about the other means. We will honor requests if required by law or if we determine in our sole discretion to do so. We may comply with qualified requests by supplying a copy or access to the relevant PI within a reasonable time, but no less time than is needed by us or others for processing or altering databases in the ordinary course of business. If we have a duty to require third-parties to delete or cease using PI, we may satisfy it by sending them notice to do so without further action (except as expressly required by law).

9. Special Note to International Users

The Site is hosted in the United States of America. If you are a User that is a resident of another country, or are accessing the Site from outside of the United States of America, please note that you are transferring your data to the United States of America which does not have the same data protection laws as the European Union and other regions, and by providing your data you explicitly consent to (i) the use of your data for the uses identified above in accordance with the Privacy Policy and (ii) the transfer of your data, including Personal Information, to the United States of America as indicated above.

10. Revisions to this Privacy Policy

We may modify this Privacy Policy to reflect the changes to our information practices and you should therefore periodically visit this page to be sure that you have read and agree with our most current Privacy Policy. If we make any material changes we will notify you on this Site prior to the change becoming effective.

This Privacy Policy was last revised on February 20, 2018 and is effective as of that date.

Important Safety Information

What is the most important information I should know about SUBLOCADE?

Because of the serious risk of potential harm or death from self-injecting SUBLOCADE into a vein (intravenously), it is only available through a restricted program called the SUBLOCADE REMS Program.

  • SUBLOCADE is not available in retail pharmacies.
  • Your SUBLOCADE injection will only be given to you by a certified healthcare provider.

INDICATION

SUBLOCADE™ (buprenorphine extended-release) injection, for subcutaneous use (CIII) is a prescription medicine used to treat adults with moderate to severe addiction (dependence) to opioid drugs (prescription or illegal) who have received an oral transmucosal (used under the tongue or inside the cheek) buprenorphine-containing medicine at a dose that controls withdrawal symptoms for at least 7 days. SUBLOCADE is part of a complete treatment plan that should include counseling.

In an emergency, you or your family should tell the emergency medical staff that you are physically dependent on an opioid and are being treated with SUBLOCADE.

Buprenorphine, the medicine in SUBLOCADE, can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs. Call your healthcare provider right away or get emergency help if you:

  • feel faint or dizzy
  • have mental changes such as confusion
  • have slower breathing than you normally have
  • have severe sleepiness
  • have blurred vision
  • have problems with coordination
  • have slurred speech
  • cannot think well or clearly
  • have a high body temperature
  • have slowed reflexes
  • feel agitated
  • have stiff muscles
  • have trouble walking

These can be signs of an overdose or other serious problems.

Death or serious harm, including life-threatening breathing problems, can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, muscle relaxants, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with SUBLOCADE. Tell your healthcare provider if you are taking any of these medicines and if you drink alcohol.

SUBLOCADE is a controlled substance (CIII) because it contains buprenorphine that can be a target for people who abuse prescription medicines or street drugs.

Death has been reported in those who are not opioid dependent who received buprenorphine sublingually.

Do not use SUBLOCADE if you are allergic to buprenorphine or any ingredient in the prefilled syringe (ATRIGEL® Delivery System, a biodegradable 50:50 poly(DL-lactide-co-glycolide) polymer and a biocompatible solvent, N-methyl-2-pyrrolidone (NMP)).

SUBLOCADE may not be right for you. Before starting SUBLOCADE, tell your healthcare provider about all of your medical conditions, including:

  • Trouble breathing or lung problems
  • An enlarged prostate gland (men)
  • A head injury or brain problem
  • Problems urinating
  • A curve in your spine that affects your breathing (scoliosis)
  • Liver problems
  • Gallbladder problems
  • Adrenal gland problems
  • Addison’s disease
  • Low thyroid hormone levels (hypothyroidism)
  • A history of alcoholism
  • Mental problems such as hallucinations (seeing or hearing things that are not there).
  • Are pregnant or plan to become pregnant. Opioid-dependent women on buprenorphine maintenance therapy may require additional analgesia during labor. If you receive SUBLOCADE while pregnant, your baby may have symptoms of opioid withdrawal at birth.
  • Are breastfeeding or plan to breastfeed. SUBLOCADE can pass into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby during treatment with SUBLOCADE. Watch your baby for increased drowsiness and breathing problems.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. SUBLOCADE may affect the way other medicines work and other medicines may affect how SUBLOCADE works. Some medicines may cause serious or life-threatening medical problems when taken with SUBLOCADE. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

The doses of certain medicines may need to be changed if used during treatment with SUBLOCADE. Do not take any medicine during treatment with SUBLOCADE until you have talked with your healthcare provider. Your healthcare provider will tell you if it is safe to take other medicines during treatment with SUBLOCADE.

You should not take anxiety medicines or benzodiazepines (such as Valium® or Xanax®), sleeping pills, tranquilizers, muscle relaxants, or sedatives (such as Ambien®), antidepressants, or antihistamines that are not prescribed to you during treatment with SUBLOCADE, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death. If a healthcare provider is considering prescribing such a medicine for you, remind the healthcare provider that you are being treated with SUBLOCADE.

You may have detectable levels of SUBLOCADE in your body for a long period after stopping treatment with SUBLOCADE.

What should I avoid while being treated with SUBLOCADE?

  • Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medicine affects you. Buprenorphine can cause drowsiness and slow reaction times. This may happen more often in the first few days after your injection and when your dose is changed.
  • Do not drink alcohol during treatment with SUBLOCADE, as this can lead to slowed breathing, drowsiness, slow reaction time, loss of consciousness or even death.

What are the possible side effects of SUBLOCADE?

SUBLOCADE can cause serious side effects, including:

  • Physical dependence and withdrawal. Your body can develop a physical need for SUBLOCADE (dependence). If you stop receiving SUBLOCADE, you could have opioid withdrawal symptoms such as:
    • shaking, goose bumps, muscle aches
    • sweating more than normal
    • feeling hot or cold more than normal
    • runny nose and watery eyes
    • diarrhea or vomiting

    These symptoms may start weeks to months after your last dose of SUBLOCADE.

  • Liver problems. Call your healthcare provider right away if you notice any of these signs of liver problems:
    • your skin or the white part of your eyes turns yellow (jaundice)
    • urine turns dark
    • bowel movements (stools) turn light in color
    • decreased appetite
    • stomach (abdomen) pain or nausea

    Your healthcare provider may do tests before and during treatment with SUBLOCADE to check your liver.

  • Allergic reaction. Call your healthcare provider or get emergency help right away if you get:
    • rash, hives, itching
    • swelling of your face
    • wheezing
    • dizziness, or a decrease in consciousness
  • Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down.
  • The most common side effects of SUBLOCADE include:
    • constipation
    • headache
    • nausea
    • injection site itching
    • vomiting
    • increase in liver enzymes
    • tiredness
    • injection site pain
  • Long-term (chronic) use of opioids, including SUBLOCADE, may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects. Call your healthcare provider for medical advice about side effects.

To report pregnancy or side effects associated with taking SUBLOCADE, please call 1-877-782-6966. You are encouraged to report negative side effects of drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information about SUBLOCADE, see the full Prescribing Information including BOXED WARNING, and Medication Guide or talk to your healthcare provider. For REMS information visit www.sublocadeREMS.com.

You are encouraged to report negative side effects of drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.